The Food and Drug Administration plans to hold a public hearing next month on the use of drugs and biological products labeled as homeopathic, its first evaluation in 25 years of the regulatory framework involving such products.
The hearing April 20-21 reflects a potential shift in the agency's view of homeopathic medicines in light of the segment's major growth in recent years.
Sales of homeopathic and herbal medicine reached more than $6.4 billion in 2012, according to market research firm Mintel, which amounted to a 3% increase over 2011 and a 16% rise during the past five years.
Originated in Germany during the 1700s, homeopathy is based on the concept that substances that cause disease symptoms in a healthy person can be used to cure a person sick with similar symptoms.
The FDA has regulated homeopathic products within its current framework since 1990 under the agency's Compliance Policy Guide, Conditions Under Which Homeopathic Drugs May be Marketed.
The rule subsequently allowed homeopathic products to be sold either by a prescription or over the counter. Such drugs must meet standards for product strength, quality and purity set forth in the Homeopathic Pharmacopeia of the United States. But according to the CPG, meeting those standards “…does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.”
Questions have been raised for years regarding the efficacy of homeopathic treatments, with critics arguing that such products amount to nothing more than pseudoscience.
A recent study released by the Australian government's National Health and Medical Research Council found there were no health conditions for which researchers found reliable evidence homeopathic medicines were effective.
“Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious,” the report concluded. “People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.”